UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016578
Receipt No. R000019225
Scientific Title Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions: A comparative analysis of quantitative vessel angiography and intravascular ultrasound and computed tomography
Date of disclosure of the study information 2015/02/23
Last modified on 2016/03/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions: A comparative analysis of quantitative vessel angiography and intravascular ultrasound and computed tomography
Acronym Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions
Scientific Title Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions: A comparative analysis of quantitative vessel angiography and intravascular ultrasound and computed tomography
Scientific Title:Acronym Examination about accuracy of quantitative vessel angiography during endovascular treatment for femoropopliteal lesions
Region
Japan

Condition
Condition Peripheral arterial disease (PAD)
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation about accuracy of quantitative vessel angiography (QVA) during endovascular treatment for femoropopliteal lesions
Basic objectives2 Others
Basic objectives -Others Evaluation about accuracy of parameters measured by QVA
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Differences of vessel diameters measured by QVA and intravascular ultrasound (IVUS).
2. Differences of stent length measured by QVA, CT and IVUS.
Key secondary outcomes Relationship between distance from calibration point and each accuracy

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Age>=20, male or female.
2.Getting informed consent form a patient or legal guardian.
3.Rutherford classification category 2-6 (including critical limb ischemia) and significant stenotic lesion in the femoropopliteal artery.
4.Patient scheduled to receive stent implantation.
5.Patient who already received stent implantation, and scheduled to receive endovascular therapy.
Key exclusion criteria 1. Previous history of allergy to contrast materials and materials used in the investigational device.
2. Estimated glomerular filtrateion rate is less than 30ml/min/1.73m2. Hemodialysis patient are not excluded.
3. Patient who is determined to be unsuitable for this study by principal investigator or subinvestigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinsuke Mori
Organization Saiseikai Yokohama City Eastern Hospital
Division name Cardiology
Zip code
Address 3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa.
TEL 045-576-3000
Email hello_morisun@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Mori
Organization Saiseikai Yokohama City Eastern Hospital
Division name Cardiology
Zip code
Address 3-6-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa.
TEL 045-576-3000
Homepage URL
Email hello_morisun@yahoo.co.jp

Sponsor
Institute Department of Cardiology, Saiseikai Yokohama City Eastern Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 済生会横浜市東部病院
Saiseikai Yokohama City Eastern Hospital

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 23 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information Evaluation about accuracy of quantitative vessel angiography (QVA) during endovascular treatment for femoropopliteal lesions

Management information
Registered date
2015 Year 02 Month 18 Day
Last modified on
2016 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019225

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.